Lilly to Settle Zyprexa Claims

"Eli Lilly announced late Thursday that it will settle about three-quarters of the liability clams stemming from its Zyprexa schizophrenia drug.

"Lilly will establish a fund not to exceed $690 million for plaintiffs who agree to settle their claims. The number of claimants covered by the settlement is estimated to be 8,000, comprising about 75% of the claims." [ThsStreet.com]

Guidant issues warning on more defibrillator models

". . . [t]he latest concerns with Guidant defibrillators may force the Food and Drug Administration to put a 'recall' label on the devices. Last week, Guidant (GDT) said some of its older model defibrillators contained flaws, but those models are out of circulation. The new warning comes on devices that Guidant now is selling." [Investor's Business Daily]

Guidant's recall clouds merger status

"Guidant Corp.'s stock price sank 3 percent Monday as investor questions rose over the medical device maker's defibrillator recall and its impact on the pending takeover by Johnson & Johnson.

"Guidant's share price fell $2.16, to $70.30, its lowest price since the Indianapolis company agreed on Dec. 15 to be acquired by Johnson & Johnson." [Indystar.com]

Patients call doctors after Guidant recall

"Nervous patients called their doctors Monday to have potentially faulty implanted heart devices checked out after the company offered to replace thousands of them because of flaws.

For 44-year-old Alan Black, the potential for a short circuit in his defibrillator was enough to convince his doctor to schedule replacement surgery for June 30. The Lock Haven, Pa., resident got his device in 2002." [Seattle Post-Intelligencer]

Future of Bextra in doubt

"Pfizer Inc. wants to put its second-generation COX-2 drug Bextra back on the market but lawyers for patients who contend they were harmed by the drug warn it was approved too hastily in the first place.

[...]

"The pharmaceutical giant voluntarily suspended sales of the $1 billion-a-year anti-inflammatory painkiller April 7, one day after a 19-page Food and Drug Administration memo raised concerns of possible health risks of COX-2 inhibitors, the class of painkillers touted as being easier on the stomach lining than aspirin. Bextra, Pfizer's second generation COX-2 after the success of Celebrex, was prescribed for treatment of arthritis, rheumatism and menstrual pain." [Science Daily]

E-mails Suggest Merck May Have Known of Vioxx's Risks: Report

"Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago?

"The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack." [KLASTV.com]

News: Medical whistleblowers speak out

"The US Food and Drug Administration (FDA) was 'the single greatest obstacle to doing anything effective' about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.

"In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, 'Nearly 60,000 people probably died from that drug. That's as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn't.'" [MyDNA.com]

Whether older NSAIDs like ibuprofen pose risks like Vioxx, Bextra still unknown DRUG Q & A RICHARD HARKNESS

"Reading news releases during the past months has been like watching an infection spread. First to get the cardiovascular risk bug was Vioxx. Next, Celebrex came down with it, then Bextra. Finally, the traditional NSAID naproxen appeared to catch it, causing suspicions to spread through the entire lot." [Times-Leader]

Tens of thousands of cases seen in Vioxx litigation

"A federal judge told dozens of lawyers crowded into a courtroom here Monday that there could ultimately be up to 100,000 cases filed against Merck (MRK) over its now-withdrawn pain reliever Vioxx, and that he could hear a case as early as the fall.

"There have been more than 2,000 cases filed against the Whitehouse Station, N.J.-based drugmaker so far. The pretrial issues for federal cases are being handled by U.S. District Court Judge Eldon Fallon, and lawyers from both sides met here for a monthly status conference." [USA Today]

FDA races to keep up with drug ads that go too far

"The TV commercial for the drug Enbrel was upbeat, engaging and, the Food and Drug Administration said, misleading.

"A young woman ran on a beach, flinging off her top to reveal her swimsuit and perfect skin. 'Want to get psoriasis off your back?' the voice-over asked." [USA Today]